Services
  • Establish web-based Quality Management Systems  (QMS) Part 11 compliant
  • 21 CFR 820 QSR audits, Mock FDA audits, GAP Analysis, Quality Planning (ISO 10005)
  • Corrective and Preventive Actions; Managing closure of US FDA Warning Letters
  • 510(k) and de novo submissions
  • electronic MDR Agent (21 CFR 803)
  • US Agent
  • CMDCAS, ISO 13485, CE Marking certifications
  • EU Tech Files, Risk Management Files (ISO 14971), Usability Engineering Files (IEC 62366), Software (IEC 62304)
Satisfaction
We exceed expectations.
Reliability
We’re here when you need us.

Contact us

Results Oriented 
Submissions and Compliance
Global Medical Device Consultants
612-889-5168

Six webinars that help plan your transition.  Available for purchase individually or as a series.  

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MedTech Review delivers results

Our team covers a wide range of services to meet your medical device submission, regulatory compliance, and quality management system needs. We specialize in helping our clients save both time and money. 

Workmanship
We pay attention to the details.

We are seasoned professionals

building effective compliance programs and submissions

for medical device manufacturers.


We believe a medical device is only valuable when it's available.  And like you, we feel the urgency to place safe and effective medical devices in markets around the world

and keep them there.​